Calliditas Therapeutics AB (publ) (”Calliditas”) today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company for the treatment of Autoimmune hepatitis (AIH). More information about the ODD has been posted on www.fda.gov.
AIH is a chronic, autoimmune disease of the liver that occurs when the body’s immune system attacks liver cells causing the liver to be inflamed. The disease may occur in any ethnic group and at any age but is most often diagnosed in patients between age 40 and 50. It is estimated that the patient population in the US amounts to approximately 50,000.
Today there is a significant unmet medical need related to lack of tolerability and side effects of systemic steroids which are administered to patients. The company plans to agree the regulatory pathway for this indication in consultation with the FDA later this year.